MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK SHOULDER GLENOID GLOBAL APG+

Catalog Number UNK SHOULDER GLENOID GLOBAL AP

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Osteolysis (2377); Unspecified Tissue Injury (4559)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article reviewed.Iannotti jp, jun bj, derwin ka, ricchetti et.Stepped augmented glenoid component in anatomic total shoulder arthroplasty for b2 and b3 glenoid pathology: a study of early outcomes.J bone joint surg am.2021 oct 6.Pmid: 33989252.The article's purpose was to assess the use of a stepped augmented glenoid component for management of walch b2 and b3 glenoid.Patient data: 30 females and 62 males.Pre-op all patients had advanced glenohumeral osteoarthritis with an intact rotator cuff.Depuy products: global ap humeral components and poly global anchor peg glenoid component.Cement manufacturer is not provided within the article.Adverse events (n = specific number of events not provided): (n) glenoid migration ¿ no treatment noted.(n) osteolysis ¿ no treatment noted.(5) transient axillary nerve injury ¿ 4 resolved spontaneously, 1 residual dysesthesias.(1) biceps tenodesis ¿ revision.(1) infection ¿ arthroscopy.(2) failed lesser-tuberosity osteotomy repair ¿ revision.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: UNK SHOULDER GLENOID GLOBAL APG+
• Type of Device: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15074659
• MDR Text Key: 296304196
• Report Number: 1818910-2022-13640
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOID GLOBAL AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention